| CTRI Number |
CTRI/2023/06/054210 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LEECH THERAPY] |
| Study Design |
Other |
|
Public Title of Study
|
An open labelled non randomized phase II clinical trial to evaluate the efficacy of leech therapy in siddha in the management of osteoarthritis |
|
Scientific Title of Study
|
An open labelled non randomized phase II clinical trial to evaluate the efficacy of attaividal (leech therapy in siddha external therapy) in the management of azhal keel vayu(Osteoarthritis) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Shanmu |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical colege and hospital |
| Address |
II year pg scholar Department of Pura Maruthuvam, Government siddha medical College and hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
vishnu31190@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Ganesan |
| Designation |
Lecturer Grade II |
| Affiliation |
Government siddha medical College and hospital, palayamkottai |
| Address |
Department of Pura Maruthuvam, Government siddha medical
College and hospital, Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Ganesan |
| Designation |
Lecturer Grade II |
| Affiliation |
Government siddha medical College and hospital, palayamkottai |
| Address |
Department of Pura Maruthuvam, Government siddha medical
College and hospital, Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central library of Government siddha medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Dr R Shanmu |
| Address |
II year PG scholar Department of Pura Maruthuvam, Government
siddha medical College and hospital, Palayamkottai, Tirunelveli
627002 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR R Shanmu |
Government siddha medical College and hospital |
Department of Pura Maruthuvam, Government
siddha medical College and hospital, Palayamkottai, Tirunelveli
627002
Tirunelveli
TAMIL NADU |
9500966437
vishnu31190@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ATTAI VIDAL (external therapy) |
Hirudoventralis type of leech which have a Size of
2 to 3 inches, a number of
2 to 3 leeches for 3 to 5 times for about 45 minutes to 1 hour will be applied around the affected knee joint depending upon the severity of disease.
Time interval between the two Leech Application is Seven days
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms of pain in single or both knee joints, swelling, tenderness, stiffness, crepitation, restricted movements.
2.Patients who are willing to undergo Leech application
3.Willing to give specimen of blood for investigation whenever required.
4.Willing to attend OPD or admission in IPD for 48days.
5.Willing to take photograph before and after treatment.
|
|
| ExclusionCriteria |
| Details |
1.History of Tuberculosis
2.History of Hepatitis B, AIDS, syphilis.
3.History of Heamophilia& Anticoagulant treatment
4.Pregnancy & lactation
5.Rheumatoid and other types of arthritis
6.Benign and malignant neoplasm
7.Trauma, Fracture, Ligament injury
8.Immuno compromised Patients
9.History of Psychiatric disorder
10.Surgery of the affected knee joint during the previous 3 month or joint replacement.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in severity of joint pain, stiffness, tenderness & swelling |
2weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open labelled non randomized phase II clinical trial to evaluate the efficacy of attaividal (leech therapy in siddha external therapy) in the management of azhal keel vayu(Osteoarthritis).The primary objective is to evaluate the improvement of clinical signs & symptoms in azhal keel vayu (osteoarthritis)patients before and after treatment of leech therapy . Hirudoventralis (leech) which have a size of 2 to 3 inches, in a number of 2 to 3 leeches for 3 to 5 sittings (based on severity of disease) for about 45 minutes to 1 hour will be introduced around the affected knee joint. Time interval between the first and next consecutive leech therapy application session will be Seven days.In case of any adverse events (AE) is noticed, it will be referred to pharmacovigilence department and Further management of patients will be given in OPD. |